When used with anterior screw fixation or posterior hook, non-pedicle screw fixation the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

Device Description

The MOSS MIAMI System is available in either Stainless Steel or Titanium. The following components are available in Stainless Steel: longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, hooks, reduction hooks, transverse connectors, axial connectors, staple washers and sacral extenders. The following components are available in Titanium: longitudinal rods, monoaxial screws, polyaxial screws, hooks, transverse connectors, axial connectors, washers, staple washers, and sacral extenders. The design, intended use, and material of these components have been cleared in previous 510(k) submissions.

AI/ML Overview

The provided text is a 510(k) summary for the DePuy Motech MOSS Miami Spinal System and a clearance letter from the FDA. It does not describe any specific acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures typically associated with modern medical device studies, particularly for AI/software devices.

Instead, the document focuses on the regulatory acceptance of the device based on its substantial equivalence to previously cleared predicate devices. The "acceptance criteria" here are essentially the FDA's requirements for demonstrating substantial equivalence for marketing.

Here is a breakdown of the requested information based on the provided text, noting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from FDA Clearance)	Reported Device Performance (from 510(k) Summary)
General Use (anterior screw fixation or posterior hook, non-pedicle screw fixation):	Intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
Pedicle Screw Fixation Use (Specific Limitations):	Intended for use in patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
Substantial Equivalence:	Components are identical to components of other MOSS Miami Spinal Systems previously cleared by FDA for anterior, posterior, and pedicle fixation uses. An insertion tool has been included for ease of implantation.
Regulatory Compliance:	- Required annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration (General Controls).- All labeling must state explicit limitations for pedicle screw use as described in the letter.- No labeling or promotion for pedicular screw fixation/attachment other than severe spondylolisthesis (Grades 3 and 4 L5-S1).- Specific warnings must be included in the package insert about pedicle screw use limitations and potential risks.- Use for pedicular screw fixation for other indications is considered investigational and requires IDE regulations compliance.- Compliance with Quality System Regulation (21 CFR Part 820).
Warning Statements:	Previous warning statements about components not approved for screw fixation into pedicles must be replaced by the specific warnings defined in the clearance letter.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable / Not provided. The summary for this orthopedic implant device focuses on substantial equivalence based on design and material similarity to previously cleared devices, not on a clinical performance study with a "test set" in the context of a software or diagnostic device. No patient data or clinical study population is mentioned for performance evaluation in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable / Not provided. Ground truth establishment by experts is not described, as this is neither an AI device nor a diagnostic device that requires such evaluation in the context of this 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable / Not provided. Adjudication methods are not relevant to this type of device submission as described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable / Not provided. This is not an AI-assisted device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Not provided. This is an orthopedic implant, not an algorithm, so standalone performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable / Not provided. The "ground truth" here is regulatory acceptance based on substantial equivalence to predicate devices, not clinical truth derived from patient data.

8. The sample size for the training set

Not Applicable / Not provided. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable / Not provided. This is not an AI/ML device that requires ground truth for a training set.

Summary of the Document's Focus:

This 510(k) submission exemplifies a pre-AI era device clearance for an orthopedic implant. The "acceptance criteria" discussed are primarily regulatory in nature, focusing on:

Demonstrating that the device (MOSS Miami Spinal System components) is "substantially equivalent" to predicate devices (other MOSS Miami Spinal Systems).
Defining the specific "Indications for Use," particularly the stringent limitations for pedicle screw fixation.
Ensuring appropriate labeling and warnings are in place to mitigate risks associated with the device, especially concerning pedicle screw use.

There is no mention of performance metrics (sensitivity, specificity, accuracy), clinical study results, or data analyses typical of AI/software medical devices. The "study" here is the submission itself, demonstrating compliance with regulatory standards for substantial equivalence, rather than a clinical trial proving a specific performance metric.

Summary

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AUG 6 1998

MOTECH ™ 510(k) SUMMARY OF SAFETY AND EFFECTIVENE THE NATURAL BALANCE

1982011

NAME OF FIRM:

DePuy Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

510(K) CONTACT:

Manager, Clinical and Regulatory Affairs

TRADE NAME:

COMMON NAME:

DEVICE PRODUCT CODE AND CLASSIFICATION:

SUBSTANTIALLY EQUIVALENT DEVICES: Lynnette Whitaker

DePuy Motech MOSS Miami Spinal System

Rod and screw spinal instrumentation

87 KWP. Classification 888.3050 87 KWQ, Classification 888.3060 87 MNH, Unclassified

DePuy Motech MOSS Miami Spinal System, DePuy Motech MOSS Miami Spinal System, Pedicle Fixation DePuy Motech MOSS Miami Spinal System, Anterior Use.

DePuy Motech Titanium MOSS Miami Spinal System

DEVICE DESCRIPTION AND INTENDED USE:

The MOSS Miami Spinal System is intended for non-cervical use in the spine.

700 ORTHOPAEDIC DRIVE . P.O. BOX 988 WARSAW, IN 46581-0988 TELEPHONE 1-219-267-8143

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67/23/98

DEPUY

When used with pedicle screw fixation, the MOSS Miami Spinal System is intence which used with severe spondylolisthesis (Grades 3 and 4) at the L 5-ST vertebrad Journ having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The components of the MOSS Miami Spinal System are identical to the components of the other MOSS Miami Spinal Systems which have been cleared by FDA for certain anterior and posterior uses and for pedicle fixation use indications. An insertion tool has been included with the components for ease of implantation.

700 ORTHOPAEDIC DRIVE • P.O. BDX 988 WARSAW, IN 46581-0988 TELEPHONE 1-219-267-8143

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 6 1998

Ms. Lynnette Whitaker Manager, Clinical and Regulatory Affairs DePuy Motech™ 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K982011

Reduction Screws and Hooks - to be used as part of the MOSS-Miami Spinal System Regulatory Class: II Product Codes: MNH, KWP, and KWQ Dated: June 4, 1998 Received: June 8, 1998

Dear Ms. Whitaker:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act (Act). This decision is based on your device system being found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f)(1) of the Act.

This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

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Page 2 - Ms. Lynnette Whitaker

All labeling for this device, including the package label, must state that there are 1. labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral ioint: (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
1. You may not label or in anyway promote this device system for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:

WARNINGS:

. When used as a pedicle screw system, this device system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
. The screws of this device system are not intended for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
. Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
. Potential risks identified with the use of this device system, which may require additional surgery, include:
- device component fracture, loss of fixation, non-union, fracture of the vertebra. neurological injury, and vascular or visceral injury.

See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.

1. Any pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR. Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other

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than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.

Any previous warning statements identified as part of previous 510(k) clearances or 4. required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the

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Page 4 - Ms. Lynnette Whitaker

Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ન Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number 982011

Device Name

DePuy Motech MOSS Miami Spinal System, Additional Screw Components

Indications for Use:

The MOSS Miami Spinal System is intended for non-cervical use in the spine.

Concurrence of CDRH, Office of Device Evaluation

boell

Prescription Use

OR (Per 21 CFR 801.109) Over-The Counter Use

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.